Chronic Pain, Nociceptive Pain, Pain
Conditions
Keywords
Chronic Pain, Nociceptive Pain, Mixed Pain, Cannabinoid, Cannabinoid-2 Receptor Agonist
Brief summary
A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.
Interventions
DRUGCNTX-6016
Oral Dose CNTX-6016
OTHEROther: Placebo
Oral Dose Placebo
Sponsors
Centrexion Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Is in good general health as determined by Investigator's review. * Has a body mass index (BMI) between 18 and 35 kg/m2. * Non- or ex-smoker (\> 1 year) and has not used any nicotine containing products within 12 months prior to screening. * For females, is not currently pregnant and is either of non-childbearing potential or willing to use an adequate method of birth control. * For males, must agree to use barrier contraception and not to donate sperm. Key
Exclusion criteria
* History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia. * Has any history or currently active type of cancer except excised or cured basal cell carcinoma. * Has a gastrointestinal disorder that could interfere with the absorption of orally administered drugs. * Has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medicine. * Currently has kidney, neurologic, metabolic, or liver disease, or other organ system disease. * Has a history, current evidence, or is being treated for depression, suicidal ideation, suicide attempt, or any other current psychiatric condition requiring active treatment. * Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection. * Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV). * Is pregnant, lactating, or planning a pregnancy during the study. * Has used any prescribed medication within 30 days prior to the first admission or has plans to use any prescribed medication during the study (with the exception of hormonal contraceptives). * Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse. * Ingestion of food or beverages containing grapefruit and/or grapefruit juice and/or pomelos during the 7 days prior to dosing and/or during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Excretion | Up to 6 days | Urine was collected over a 3-day period (0-72 hrs) in Cohort 8 and analyzed for concentrations of CNTX-6016 in subjects in both the fasted and fed states using Liquid Chromatography Mass Spectrometry. |
| Effect of Gender on CNTX-6016 Pharmacokinetics - t1/2 | Up to 80 days | Effect of Gender on the systemic exposure to CNTX-6016 measured by t1/2 |
| Effect of Gender on CNTX-6016 Pharmacokinetics - AUC | Up to 80 days | Effect of Gender on the systemic exposure to CNTX-6016 measured by AUC. |
| Safety of single doses of CNTX-6016 - TEAEs | Up to 80 days | Information regarding treatment emergent adverse events was collected during each dose cohort. |
| Dose Proportionality of a single doses of CNTX-6016 in healthy subjects | 40 days | Dose Proportionality of a single doses of CNTX-6016 in healthy subjects. |
| CNTX-6016 Pharmacokinetics - Cmax | Up to 40 days | Systemic exposure to CNTX-6016 measured by Cmax. |
| CNTX-6016 Pharmacokinetics - Tmax | Up to 40 days | Systemic exposure to CNTX-6016 measured by Tmax. |
| CNTX-6016 Pharmacokinetics - t1/2 | Up to 40 days | Systemic exposure to CNTX-6016 measured by t1/2. |
| CNTX-6016 Pharmacokinetics - AUC 0-t | Up to 40 days | Systemic exposure to CNTX-6016 measured by AUC 0-t. |
| CNTX-6016 Pharmacokinetics - AUC 0-inf | Up to 40 days | Systemic exposure to CNTX-6016 measured by AUC 0-inf. |
| CNTX-6016 Pharmacokinetics - AUC 0-t/inf | Up to 40 days | Systemic exposure to CNTX-6016 measured by AUC 0-t/inf. |
| CNTX-6016 Pharmacokinetics - CL/F | Up to 40 days | Systemic exposure to CNTX-6016 measured by CL/F. |
| CNTX-6016 Pharmacokinetics - Vz/F | Up to 40 days | Systemic exposure to CNTX-6016 measured by Vz/F. |
| Effect of Gender on CNTX-6016 Pharmacokinetics - Cmax | Up to 80 days | Effect of Gender on the systemic exposure to CNTX-6016 measured by Cmax. |
| Effect of Gender on CNTX-6016 Pharmacokinetics - Tmax | Up to 80 days | Effect of Gender on the systemic exposure to CNTX-6016 measured by tmax. |
| Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Cmax | Up to 40 days | Systemic exposure to CNTX-6016 in fasted or fed state as measured by Cmax |
| Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - Tmax | Up to 40 days | Systemic exposure to CNTX-6016 in fasted or fed state as measured by Tmax |
| Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - t1/2 | Up to 40 days | Systemic exposure to CNTX-6016 in fasted or fed state as measured by t1/2 |
| Effect of Fasted or Fed State on CNTX-6016 Pharmacokinetics - AUC | Up to 40 days | Systemic exposure to CNTX-6016 in fasted or fed state as measured by AUC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma and Urine Metabolite Mining | 5 days | Urine was collected over a 3-day period (0-72hrs) in Cohort 9 (1000mg) and analyzed for concentrations of parent and metabolites of CNTX-6016 using Liquid Chromatography Mass Spectrometry. |
Countries
United States
Outcome results
None listed